Magnetic Resonance Imaging in Evaluating Response to RadiationTherapy in Patients With High Grade Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01018329
First received: November 19, 2009
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying magnetic resonance imaging in response to radiation therapy in patients with high grade glioma.


Condition Intervention
Brain Tumor
Procedure: Magnetic Resonance Imaging
Procedure: Diffusion Tensor Imaging
Procedure: Magnetic Resonance Spectroscopic Imaging
Procedure: Dynamic Contract-Enhanced magnetic resonance imaging
Procedure: Diffusion-weighted magnetic resonance imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multimodality Statistical Model of Early Response of High Grade Glioma to Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Early brain tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early therapeutic-induced changes in normal surrounding brain [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6 and then 4-6 weeks after completion of radiation therapy.Patients undergo MRI imaging at baseline, weeks 1, 2, 3, 5, 6 and then 6 weeks after radiation therapy.
Procedure: Magnetic Resonance Imaging
Other Name: MRI,NMR imaging, NMRI, nuclear magnetic resonance imaging
Procedure: Diffusion Tensor Imaging Procedure: Magnetic Resonance Spectroscopic Imaging
Other Name: 1H-nuclear magnetic resonance spectroscopic imaging, Proton Magnetic Resonance Spectroscopic Imaging
Procedure: Dynamic Contract-Enhanced magnetic resonance imaging
Other Name: DCE-MRI
Procedure: Diffusion-weighted magnetic resonance imaging
Other Name: diffusion-weighted MRI

Detailed Description:

Detailed DescriptionOBJECTIVES:

I. To develop a multimodality statistical model to act as a surrogate marker scheme of early changes in high grade glioma patients undergoing radiation therapy, using conventional MRI, MR diffusion tensor imaging, perfusion, permeability, and spectroscopic imaging while incorporating the radiation dose calculations delivered locally and the results of a clinical questionnaire into the model.

II. To assess treatment response to tumor and normal tissue changes. OUTLINE: Patients undergo multimodality MRI imaging at baseline, weeks 1, 2, 3, 5, and 6, and then 4-6 weeks after completion of radiation therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients being treated for diagnosed with high grade glioma (WHO grade III or IV) at the University of Pennsylvania Medical Center who will be undergoing radiation therapy to the brain
  • Patient or legal representative able to provide written informed consent
  • Adult males and nonpregnant females

Exclusion Criteria:

  • Vulnerable populations as specified (including pregnant patients, prisoners, patients with pacemakers or metallic implants)
  • Patients with renal failure
  • Patients with any condition considered a contraindication to MRI
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01018329

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01018329     History of Changes
Other Study ID Numbers: UPCC 12309
Study First Received: November 19, 2009
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Adult Brain Tumor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014